In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT01237106

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-11-30

Brief Summary

This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.

In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).

Conditions

Polycystic Ovarian Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In Vitro Maturation (IVM)

Group Type: EXPERIMENTAL

IVM

Intervention Type: OTHER

all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.

Interventions

IVM

all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.

2. A diagnosis of PCOS by their primary MD

3. An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion

4. A day 3 FSH level of <8 IU/mL

5. In good general health off of current medications which may confound response to study medications.

6. Desire to seek pregnancy actively during the study period by IVF-ICSI.

7. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.

8. Male partner able to provide adequate semen sample by ejaculation (no TESE)

Exclusion Criteria

1. Current pregnancy

2. Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.

3. Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).

4. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.

5. Patients with significant anemia (Hemoglobin < 10 mg/dL).

6. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

7. have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Reproductive Associates

OTHER

Sponsor Role: lead

Responsible Party

Peter McGovern, MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter G. McGovern, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

University Reproductive Associates

Hasbrouck Heights, New Jersey, United States

University Reproductive Associates

Hoboken, New Jersey, United States

Countries

United States

Other Identifiers

IRB 0120100297

Identifier Type: -

Identifier Source: org_study_id